BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PFU CUP

    MDR report key: 6427177 · Received March 23, 2017

    Report

    Report Number
    0001825034-2017-01875
    Event Type
    Injury
    Date Received
    March 23, 2017
    Report Date
    March 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT OCCURRED IN (B)(6). IT HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET, AS ITS LOCATION IS UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PALOMÄKI, A., LEMPAINEN, L., MATILAINEN, M., ESKELINEN, A., REMES, V., VIROLAINEN, P., MÄKELÄ, K.T. (2017). SURVIVAL OF UNCEMENTED CUPS FROM A SINGLE MANUFACTURER IMPLANTED FROM 1985 TO 2103: FINNISH ARTHROPLASTY REGISTER DATA. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 137, 311-320.

    Description of Event or Problem · 1

    IT IS REPORTED THAT 27 PATIENTS UNDERWENT REVISION SURGERY DUE TO FAILED PLACEMENT OF THE ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209609 UNKNOWN PFU CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN FEMORAL HEAD| UNKNOWN HEXLOC LINER| UNKNOWN RINGLOC LINER